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Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01628887
Recruitment Status : Terminated (Proposal will not be submitted and low accrual.)
First Posted : June 27, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
This clinical trial studies a supportive education program for Latina breast cancer survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast cancer survivors know what to expect after completing breast cancer treatment and prepare them to cope with cancer related survivorship issues

Condition or disease Intervention/treatment Phase
Cancer Survivor Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Other: Educational Intervention Not Applicable

Detailed Description:
PRIMARY OBJECTIVES: I. Describe the feasibility of implementing the BBCEI. II. Describe the cultural and linguistic appropriateness of the BBCEI. III. Determine topics requiring further emphasis in the BBCEI. IV. Identify ways to enhance program content, format, and materials. OUTLINE: Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (BBCEI)
Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.
Other: Educational Intervention
Undergo Bilingual Breast Cancer Educational Intervention




Primary Outcome Measures :
  1. Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI) [ Time Frame: 2 months after completion of the educational session ]
    A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials.

  2. Determine the cultural and linguistic appropriateness of the BBCEI [ Time Frame: 2 months after completion of the educational session ]
    A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials

  3. Determine topics requiring further emphasis in the BBCEI [ Time Frame: 2 months after completion of the educational session ]
    A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials

  4. Determine ways to enhance program content, format and materials [ Time Frame: 2 months after completion of the educational session ]
    A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

The population will consist of Latinas with breast cancer who have completed primary cancer treatment. A total of 10 subjects will be accrued.

Inclusion Criteria:

  • Diagnosis of Stage I, II or III.
  • Self-identification as Hispanic/Latina.
  • Able to read and understand English or Spanish to participate in the education sessions.
  • Ability to read and/or understand the study protocol requirements, and provide written informed consent
  • Subjects maybe be on hormonal therapy after treatment for initial breast cancer.

Exclusion Criteria:

  • Actively receiving treatment with surgery, radiation therapy, or chemotherapy.
  • Patients who have recurrence, metastasis, or a second primary cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628887


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Gloria Juarez, PhD City of Hope Medical Center

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01628887     History of Changes
Other Study ID Numbers: 12175
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by City of Hope Medical Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases